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Oxford Ovarian Cancer Predict Chemotherapy Response 01 (OXO-PCR-01)

This study is currently recruiting participants.
Verified January 2013 by University of Oxford
Sponsor:
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01770535
First received: January 15, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

The purpose of the study is to understand why there are differences between individuals in the way they respond to paclitaxel chemotherapy.


Condition
Ovarian Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Single-Centre Prospective Phase 0 Translational Study for Predicting Response of High Grade Serous Ovarian Cancers to Paclitaxel Chemotherapy

Resource links provided by NLM:

Drug Information available for: Paclitaxel
U.S. FDA Resources

Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Correlation between βIII tubulin expression and Mitotic Index (MI) following single agent paclitaxel treatment [ Time Frame: Before and 24-hours after paclitaxel treatment ] [ Designated as safety issue: No ]
    Correlation between βIII tubulin expression and Mitotic Index (MI) before and after single agent paclitaxel treatment to determine whether overexpression of βIII tubulin is associated with Paclitaxel resistance


Secondary Outcome Measures:
  • Correlation between mitotic index and the magnitude of CA125 response [ Time Frame: three weeks after paclitaxel treatment ] [ Designated as safety issue: No ]
    Correlation between mitotic index and the magnitude of CA125 response will be analysed to investigate whether post-paclitaxel mitotic index is a determinant of clinical response in ovarian cancer


Biospecimen Retention:   Samples With DNA

Ovarian cancer biopsy tissue samples Eyebrow hair follicles Blood samples Surgical tissue samples


Estimated Enrollment: 35
Study Start Date: November 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Detailed Description:

While paclitaxel is very effective in killing cancer cells in a proportion of patients, some patients don't respond to this treatment. As with any chemotherapy, paclitaxel is associated with unpleasant side effects. We are doing this study to try and understand what is happening in cancer cells in different individuals after paclitaxel treatment that make them respond differently to the same treatment. We hope that this study will enable us to develop a method to identify women who are suitable for this form of treatment. We also want to understand why some cancer cells don't get killed with paclitaxel. This information will help us to select treatment to suit an individual patient, and thus improve the outcome of treatment and avoid giving treatment that will not benefit the patient.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with radiological and histological evidence of advanced ovarian cancer, who would standardly be managed by primary chemotherapy and interval debulking surgery

Criteria

Inclusion Criteria:

  • Female ≥ 18 years of age
  • Newly diagnosed and histology confirmed primary high grade serous ovarian cancer, high grade serous fallopian tube cancer and primary peritoneal carcinoma.
  • Radiological and laparoscopic confirmation of FIGO stage 3C or 4 ovarian cancer.
  • Radiological evidence of omental or peritoneal deposits that are accessible for radiology-guided biopsy.
  • At least one lesion on CT scan measuring at least 2 cm in maximum diameter performed in the past 31 days. Slightly older scans may be accepted at the discretion of the CI providing the results are considered to remain clinically relevant.
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
  • Life expectancy of at least 6 months.
  • The patient is willing and able to provide written informed consent and comply with the protocol for the duration of the study, and scheduled visits and examinations.
  • Acceptable haematological and biochemical indices

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01770535

Contacts
Contact: Ahmed A Ahmed ahmed.ahmed@obs-gyn.ox.ac.uk

Locations
United Kingdom
Churchill Hospital Recruiting
Oxford, United Kingdom
Principal Investigator: Ahmed A Ahmed            
Sponsors and Collaborators
University of Oxford
  More Information

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01770535     History of Changes
Other Study ID Numbers: OXO-PCR-01
Study First Received: January 15, 2013
Last Updated: January 15, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Oxford:
Ovarian cancer, paclitaxel

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
 Gonadal Disorders
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013